Cannabidiol for Treating PTSD symptoms and Neurocognitive Impairment in PTSD and PTSD Comorbid with TBI: A Placebo-controlled RCT with Neuralcircuit centered Precision Medicine Prediction of Response

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Traumatic Brain Injury
    Post Traumatic Stress Disorder
  • Age: Between 18 Year(s) - 85 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. DSM-5 current diagnosis of PTSD with the Clinician Administered PTSD Scale (CAPS-5)
    2. TBI present (for PTSD+TBI subjects only)
    3. Mild TBI (for PTSD+TBI subjects only)
    4. Able to provide at least 2 locators (contacts)
    5. Able to provide voluntary written informed consent
    6. Participants who are reliably domiciled
    7. Agreement to abstain from all other cannabinoid use for the duration of the study
    8. Willingness to use contraception if male or female of childbearing potential.

You may not be eligible for this study if the following are true:

    1. History of open head injury
    2. TBI within the last 6 months
    3. Moderate-severe TBI
    4. SUD in the last 6 months other than mild AUD or nicotine use
    5. Use of any cannabinoid containing product within the last 1 month
    6. Positive urine drug screen
    7. Currently prescribed medications with possible CBD-drug interactions
    8. Exposure to trauma in the last 30 days, including police duty or military service
    9. Psychotherapy for PTSD or other psychiatric conditions if initiated within 2 months of screening
    10. Not stable for at least 2 months on psychiatric medication, anticonvulsants, antihypertensive medication, sympathomimetic medication, estrogen replacement therapy, medications associated with neurogenesis, or steroid medication
    11. Active suicide attempt within the past year
    12. Current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months
    13. Neurologic disorder or systemic illness affecting CNS function (apart from TBI)
    14. Major medical illness
    15. Clinical diagnosis of anemia
    16. Significant laboratory abnormalities
    17. Significant allergic reactions to the drug including cannabinoids or sesame oil
    18. Those pregnant or lactating
    19. Contraindication to MRI
    20. Males and females who plan to conceive a child during or two weeks following the study
    21. Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
    22. Has a high risk of adverse emotional or behavioral reaction
    23. Inpatient psych treatment in past 12 months
    24. Active military



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